Local Clinical Trial Manager – FSP

• Lead the within-country clinical operations study team and provide matrix leadership and project management
• Act as the operational point of contact between central and country study teams
• Collaborate with medical, regulatory, supply, finance, legal, vendor, and site staff
• Conduct study feasibility and site selection; lead site selection and ensure local study performance
• Deliver assigned studies on time, within budget, and to quality expectations under applicable regulations and guidelines
• Develop and maintain country study plans, budgets, timelines, milestones, quality plans, and risk plans
• Monitor recruitment targets, patient recruitment cycle times, data quality, and audit/inspection readiness
• Troubleshoot and resolve country-level study issues and ensure site supplies and inventory
• Maintain accurate study systems and the trial master file; review study databases for accuracy
• Develop country/site risk assessments, mitigation plans, and issue escalations
• Review and approve monitoring visit reports and ensure monitoring activities are completed
• Manage study budgets, site payments, contracts, negotiations, and local vendors
• Develop local study documents, plans, manuals, informed consent forms, and translations
• Coordinate regulatory authority and ethics committee submissions, approvals, and communications
• Maintain knowledge of the study compound, protocol, disease area, local guidelines, and healthcare systems
• Assist with audits and inspections and support regulatory/compliance responses
• Train in-country staff and investigator sites; coordinate investigator, monitor, and local training meetings
• Manage safety issues and safety report handling, including SAE reporting
• Communicate with sites regarding protocol amendments and collaborate with country and cross-functional staff
• Coordinate end-of-study/program debriefs and identify process improvements
• Travel as needed for the role

• Bachelor's degree or equivalent and relevant formal academic/vocational qualification
• 1+ years of experience in a CTM role
• Previous experience in site monitoring
• Respiratory experience advantageous
• Equivalent combination of education, training, and/or directly related experience may be considered
• Strong understanding of clinical studies, drug development, sample management, and quality requirements
• Strong project management and matrix-team leadership experience
• Knowledge of local regulations, ICH-GCP guidelines, and written standards
• Excellent English written and verbal communication skills
• Proven negotiation skills
• Strong computer skills and willingness to learn evolving systems
• Ability to work effectively in a remote environment
• Flexibility, resilience, learning agility, problem-solving, conflict-resolution, analytical, strategic, and data-literacy skills
• Available and willing to travel for project-related activities
• Ability to communicate effectively with diverse groups and work under pressure while managing multiple projects
• Ability to use and learn standard office equipment and technology

• Fully remote work mode
• Standard Monday–Friday work schedule
• Training courses to improve personal/professional skills
• Opportunities to gain client-dedicated experience
• Supportive, technologically empowered work environment
• Health and wellbeing support
• Healthy and balanced working environment
• Diverse and inclusive workplace valuing varied experiences, backgrounds, and perspectives